European Changes and the news on the Cosmetics Regulation

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1、EuropeanChangesandthenewsontheCosmeticsRegulationSCANCOS,Malmø,5.-6.November2009AnnetteOrloffUnit“CosmeticsandMedicalDevices”1NewCosmeticsRegulation•Adoption:expected26.Nov.2009•Applicationdate:42months(3½years)afteradoption;exceptinteraliaCMR:1.12.2010•Implementationworkhasstarted(CPNP)Nan

2、o(SCCS)•Guidelines2TheCosmeticsRegulation(Recast)•NewCosmeticslegislationintheformofaRegulation•Introductionofnewdefinitions•CosmeticsProductsSafetyAssessment•Newrulesonsubstances:CMRandnanomaterials•Simplifiednotification•Enhancementofmarketsurveillance3Mainaspectsnotchanged(Recast)•Animal

3、testingprovisions•Labellingrequirements[cmr,nano]•Responsiblepersonhastheresponsibilityofthesafetyofcosmeticproductsmadeavailableonthemarket4Newdefinitions•"Enduser"meanseitherconsumersorprofessionalsusingthecosmeticproduct•"Seriousundesirableeffect"meansanundesirableeffectwhichresultsintem

4、poraryorpermanentfunctionalincapacity,disability,hospitalisation,congenitalanomaliesoranimmediatevitalriskordeath5SafetyAssessment•Safetyassessment(Art.10)•Responsibleperson:CosmeticproductsafetyreportIntendeduseandanticipatedsystemicexposureWeightofEvidence(reviewdata)UpdatedReport•Gui

5、deline(SME),•Diploma,•GLP6Productinformationfile(Art.11)ProductInformationfile(a)descriptionoftheproduct(b)cosmeticproductsafetyreport(c)descriptionofmanufacturingmethodGMP(d)proofofclaim,whenrelevant(e)dataonanimaltesting(3.country)10yearslastbatchplacedonthemarket7AnnexI-CosmeticProductsS

6、afetyReport•PartACPsafetyinformation1.Qualitative/quantitativecompositionofproduct2.Physical/chemicalcharacteristicsandstabilityofthecosmeticproduct3.Microbiologicalquality-challengetest4.Impurities,traces,informationaboutpackagingmaterial5.Normalandreasonableforeseeableuse8AnnexI-CosmeticP

7、roductsSafetyReportII•PartACPsafetyinformation6.Exposuretothecosmeticproduct7.Exposuretothesubstances8.Toxicologicalprofileofthesubstances9.UndesirableeffectsandseriousUE10.Informationonthecosmeticproduct9AnnexI-CosmeticProductsSafetyReportIII•PartBCPsaf